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The CONSERVE® Plus HA Acetabul: r Shells are indicated for use in total hip arthroplast! for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

• non-inflammatory degenerative joint disease such as osteoarthritis, avascular 1. necrosis, ankylosis, protrusio ac tabuli, and painful hip dysplasia;
• 2. inflammatory degenerative joint disease such as rheumatoid arthritis;
• correction of functional deformi y; and, 3.
• 4. revision procedures where other treatments or devices have failed

The CONSERVE® Plus HA Acetabular Shells are intended for single patient use only.

A Hydroxylapetite (HA) coating is being a lded to the following previously cleared CONSERVE® Shells: CONSERVE® Plus Thin Shell, CONSERVE® Plus Spiked Shell, CONSERVE® Total SuperFix Shell, CONSERVE® Plus Thick & hell

{
  "1. A table of acceptance criteria and the reported device performance": "The provided document is a 510(k) summary for a medical device, the CONSERVE® Plus HA Acetabular Shells. It states that the device is \"substantially equivalent\" to previously cleared predicate devices. Therefore, specific acceptance criteria and detailed device performance metrics (e.g., in a table format) that would typically be found in a clinical trial report are not present. The basis for acceptance is essentially the demonstration of substantial equivalence to existing devices.",
  "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "This document does not describe a study involving a test set, human subjects, or data provenance in the context of performance evaluation. The substantial equivalence argument relies on \"materials data, and testing results\" but does not specify sample sizes for these tests, nor their origin or type (retrospective/prospective)."
}

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